An Equal Opportunity Provider and Employer 

VETERINARY SERVICES MEMORANDUM NO. 800.121 

TO: Veterinary Services Leadership Team 

 Directors, Center for Veterinary Biologics 

 Biologics Licensees, Permittees, and Applicants 

 

FROM: Jack A. Shere /s/ Jack Shere on June 21, 2017 

 Deputy Administrator 

SUBJECT: Autologous Therapeutic Biologics 

I. PURPOSE 

This memorandum provides guidance on licensing autologous therapeutic biologics. 

II. BACKGROUND 

Advances in technology have allowed preparation of custom vaccines against 

individual cancers and other diseases in animals. These technologies make use of 

consistent manufacturing systems to manipulate samples from patients to create 

individualized treatments. Examples include, but are not limited to, autologous cancer 

therapies. 

These are veterinary biological products as defined in title 9, Code of Federal 

Regulations (9 CFR), part 101.2. The unique and individualized product characteristics 

have necessitated adaptations to the licensure process. 

III. DEFINITIONS 

For the purpose of this memorandum, the following definitions apply. 

Autologous therapeutic biologic. A veterinary biological product prepared for an 

individual animal under a prescription written by a licensed veterinary practitioner. The 

product consists of unique antigens or genetic sequences derived from cells or tissues 

of the animal, for use as a treatment against individual cancers and other diseases in 

animals. Autologous therapeutic biologics act primarily through the immune system or 

immune response. 

Consistent manufacturing system. A manufacturing process relying on appropriate, 

controlled, and documented procedures to prepare serials differing only with respect to 

the patient source of cells, tissues, or genetic material. 

Autologous. Derived from the same individual (i.e., involving one individual as both 

donor and recipient). 

 

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 Veterinary Services 

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 An Equal Opportunity Provider and Employer 

IV. POLICY 

The Center for Veterinary Biologics (CVB) will consider applications for licensing 

autologous therapeutic biologics produced by a consistent manufacturing system. Initially, 

the autologous therapeutic biologic will be distributed as an experimental biological product 

until definitive data to support consistent manufacturing, safe use, and an expectation of 

efficacy allow qualification for licensure as an Autologous Prescription Product. 

A. The initial application should include establishment and product applications listed 

in Veterinary Services (VS) Memorandum No. 800.50 and the following: 

1. Scientific theory. Demonstration that the mechanism of action for the proposed 

product is immunologically driven, supported by scientifically sound theory and 

peer-reviewed scientific literature. 

2. Proof of concept. Reports of product use, in which raw safety and efficacy data 

are submitted in electronic format. Refer to the CVB Web site for additional 

information on proper submission of reports (VS Memorandum No. 800.200) 

and data formats. 

3. Outline of Production. The manufacturing method must be well controlled, 

detailed, and submitted according to the attached Outline template. Refer to 

9 CFR 114.8 and VS Memorandum No. 800.206 for additional information. 

B. The CVB will determine the acceptability of the product concept. If accepted, the 

CVB will regulate the product and manufacturing procedure as an experimental 

product under 9 CFR 103.3 until sufficient data establish a record of safe use and a 

reasonable expectation of efficacy. 

1. Following notification of acceptability by the CVB, the applicant should submit 

the following to the CVB for authorization to ship the product: 

a. A protocol describing data acquisition during the experimental product stage. 

This must include: 

(1) The specific data that will be gathered from each patient. Indicate the 

minimum number of animals to be treated for each animal species and the 

type or types of cancer for which efficacy and safety will be evaluated. 

The number for each indication should be included, if applicable. 

(2) Criteria for determining product efficacy. 

(3) Criteria for assessing product safety. 
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 An Equal Opportunity Provider and Employer 

(4) How the product will be tested prior to distribution, including 

quantitation of the active component. 

b. The informed consent form that each client or animal owner must sign prior to 

receiving the experimental product. 

c. Experimental labels consistent with 9 CFR 103.3 (i.e., no trade name or 

efficacy claims) but which do not need to state the product is not for sale. 

Beneath the True Name (Autologous Prescription Product), the product shall 

be further described as “Experimental {species} {cancer type or animal 

disease} Treatment” (e.g., Experimental Canine Melanoma Treatment) or 

“Experimental {species} Cancer Treatment,” as supported by scientific 

theory, proof of concept, or submitted data. 

d. Marketing and promotional information. Product advertising and marketing is 

limited to notification of availability of the autologous therapeutic biologic for 

treatment of a cancer or specific disease, must be targeted only to licensed 

veterinarians, and must be approved by the CVB prior to use. 

e. Annual authorizations from proper officials in each State in which the product 

will be distributed. 

2. Upon satisfactory review of the items in IV.B.1, the CVB will issue an 

authorization to distribute the experimental biological product, according to 

provisions specific to the product, for 1 year. A separate shipping authorization 

from the CVB is not required prior to shipping each serial. Instead, submit 

quarterly distribution reports to the CVB no later than the 21st day of January, 

April, July, and October. Include the serial identification, animal species for 

which the serial was manufactured, doses shipped, testing conducted, and any 

adverse events reported. Any additional State authorizations may be submitted at 

this time. 

3. At the end of the year, submit a progress report describing safety and efficacy 

data collected to date. Refer to the CVB Web site for additional information on 

proper submission of reports (VS Memorandum No. 800.200) and data formats. 

The authorization to distribute experimental product may be renewed for another 

year if additional data are needed. The CVB expects sufficient data to be 

generated to support licensure within 2 years, but extensions may be requested. 
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 An Equal Opportunity Provider and Employer 

4. Distribution of experimental biological product 

a. Experimental product is distributed exclusively at the request of a licensed 

veterinarian. A request for product must include patient signalment, pertinent 

diagnostic information, and the plan of treatment. The licensed veterinarian is 

responsible for maintaining and documenting the veterinarian-client-patient 

relationship consistent with the State’s Veterinary Practice Act. 

b. Clients/owners must sign the CVB-approved informed consent form prior to 

patient treatment. 

c. Product must be labeled with the CVB-approved experimental label. 

d. The CVB may conduct an onsite inspection to evaluate the consistent 

manufacturing system. 

e. If a firm does not comply with 9 CFR 103.3 or misrepresents the product, the 

CVB may take any actions deemed necessary, including revocation of the 

authorization to distribute product. 

C. When the necessary data have been generated to support licensure, the CVB may 

issue a license for Autologous Prescription Product, product code 9PPX.XX. This 

will be a special license with many characteristics of a conditional license. 

1. A separate license is issued for each consistent manufacturing system. 

2. The license will be issued for 2 years and is renewable if there are no safety or 

efficacy concerns. 

3. Labeling must indicate the use is subject to the discretion of the prescribing 

licensed veterinarian, and must disclose that efficacy cannot be assured. Once a 

license for Autologous Prescription Product is issued, Trade Names for this class 

of prescription product will be allowed. 

4. Serial Release Testing 

a. Purity testing is conducted according to the procedures in 9 CFR 113.26(b), 

with modifications available on request for product manufactured in limited 

amounts. Modifications should be specified in the Outline of Production. 

b. A fully validated potency test is not required for Autologous Prescription 

Products, but the active component must be quantified to demonstrate 

batching consistency. 
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 An Equal Opportunity Provider and Employer 

5. The licensee is exempted from furnishing to the CVB representative samples of 

each serial prepared. Reserve samples must be selected and maintained by the 

licensee as required in 9 CFR 113.3(e), with modifications available on request 

for product manufactured in limited quantities. Modifications should be specified 

in the Outline of Production. 

6. Marketing and promotional materials must be reviewed by the CVB prior to 

publication or distribution. This will be a license restriction. Efficacy claims 

cannot be advertised. 

7. Additional license restrictions: 

a. Distribution in each State shall be limited to authorized recipients 

designated by proper State officials, under such additional conditions as 

these authorities may require; 

b. For use under veterinary supervision/prescription. 

8. A separate serial release action by the CVB is not required prior to shipping each 

serial. Instead, submit quarterly distribution reports to the CVB no later than the 

21st day of January, April, July, and October. Include the serial identification, 

animal species for which the serial was manufactured, doses shipped, testing 

conducted, and any adverse events reported. 

VI. IMPLEMENTATION/APPLICABILITY 

This policy is effective immediately. 
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Appendix, Page 1 

 An Equal Opportunity Provider and Employer 

Appendix I. Outline of Production Format for Autologous Therapeutic Biologics 

I. Composition of the Product 

A. Source and Type of Raw Material 

II. Preparation of Product 

A. Each Step of Preparation to the Completion of the Finished Product in True 

Containers 

1. Methods Used 

2. Composition of Preservative, Adjuvant, or Stabilizer, and Proportions Used; Stage 

and Method of Addition 

a. Preservative 

b. Adjuvant 

c. Stabilizer 

d. Other 

3. Standardization of the Product 

4. Serial Production 

a. Assembly of Units to Make a Serial 

b. Volume of Average Serial 

c. Volume of Maximum Serial 

d. Other Pertinent Information 

5. Volume of Fill for Each Vial Size 

6. Method and Technique of Filling and Sealing of Final Containers 

7. Amount of Antigenic Material per Dose in Final Containers 

III. Testing 

A. Purity 

B. Safety 

C. Potency (Batching Consistency) 

D. Other Tests 

E. Additional Pertinent Information 
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 An Equal Opportunity Provider and Employer 

IV. Post Preparatory Steps 

A. Form and Size of Final Containers in Which the Product is to be Distributed 

B. Collection and Storage of Representative Samples. Indicate at which steps in the 

production these samples are taken. 

C. Expiration Dating 

D. Recommended Use, Dosage, and Route of Administration 

E. Site or Sites of Manufacture 

F. Exemption from Freedom of Information Act or Confidentiality Statement